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The requiered sample were not recruited due to COVID-19 pandemic
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| Name | Class |
|---|---|
| Universidad de Antioquia | OTHER |
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To evaluate the effect of selective micro-osteoperforations (MOPs) on the amount of distal movement of the upper canine, the mesio-distal inclination of the canine and the messiah movement of the upper first molar.
Methods: Clinical trial with Split mouth design in 35 orthodontic patients with bilateral extraction of the upper first premolar, each upper canine will be randomly assigned to the intervention (MOP) or to the control side. Participants will be followed for 3 months and the investigators will take periapical radiographs, cast models and clinical measurements before and after canine retraction. The measurements will be taken by previously calibrated operators. The results are going to be determined and compared between sides, with the corresponding statistical tests and the results are going to be analyzed.
PICO QUESTION: ¿Does the amount of distal orthodontic movement of the upper canine increase in the side with MOPs compared with the side without MOPs? Population: Orthodontic patients with bilateral extraction of the upper first premolar (Split mouth design trial) Intervention: Distal movement of the upper canine with Selective MOPs (distal to canine) in one hemi-arch Comparison: Distal movement of the upper canine without MOPs in the other hemi-arch Outcome: Canine and first molar movements
GENERAL AIM:
- To evaluate the effect of selective micro-osteoperforations (MOPs) on the amount of distal movement of the upper canine, the M-D inclination of the canine and the mesial movement of the upper first molar.
METHODS
OVERVIEW OF DESIGN Study Design: Randomized controlled clinical trial in split mouth design.
The participants will be with orthodontic fixed appliances (MBT prescription slot 0.022 "x0.028", canine torque 0 °), with working arches 0.019 "x0.025" stainless steel and with bilateral extractions of the first upper premolars for 6 months or more. For this moment the crowding must be resolved and there must be a space of 3 or more millimeters between the canines and second premolars.
The 4 upper incisors will be consolidated with a 0.010 "stainless steel ligature below the arch to prevent opening of anterior spaces.
Observation:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No micro-osteoperforations (No MOPs) | No Intervention | Canine Distalization without micro-osteoperforations Distalization of the upper canine in working phase with coil spring of 100 gr of force | |
| Micro-osteoperforations (MOPs) | Experimental | Canine Distalization with micro-osteoperforations at the start of the distalization Distalization of the upper canine in working phase with coil spring of 100 gr of force |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| micro-osteoperforations (MOPs) | Procedure | three (3) micro-osteoperforations (MOPs) in the cortical and medullar bone, distal to the upper canine. These MOPs will be at the apical, medial and gingival zone of the bone located at the distal surface of the canine in the buccal and in the palatal side. The deep of the MOPs will be at 6 mm. It is going to be done with a PROPEL |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of distal movement of the upper canine | Distance from a tangent to a reference point in the palate (third palatal ruga) to the distal side of the upper canine (measured in digital models) | Change from baseline at three months |
| Inclination of the upper canine, second premolar and first molar | The angle between the long axis of the clinical crown and the reference plane the occlusal plane.(measured in digital models) | Change from baseline at three months |
| Angulation of the upper canine, second premolar and first molar | The long axis of the posterior buccal surface is going to be measured relative to the occlusal plane (measured in digital models) | Change from baseline at three months |
| Amount of mesial movement of upper first molar | Distance from a tangent to a reference point in the palate (third palatal ruga) to the mesial side of the upper first molar (measured in digital models) | Change from baseline at three months |
| Measure | Description | Time Frame |
|---|---|---|
| Periodontal status | It's going to be measured by clinical exam | Change from baseline at three months |
| Evaluation of the perception of pain by the patient: VAS | Pain visual analogue scale (AVS) - from 0 to 10 points, Higher values represent more pain perception by the participant |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UniCIEO | Bogotá | DC | 110111 | Colombia | ||
| Universidad de Antioquia |
Individual participant data is going to be share only for statistical analysis
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| ID | Term |
|---|---|
| D008644 | Mesial Movement of Teeth |
| ID | Term |
|---|---|
| D014085 | Tooth Migration |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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|
| Change from baseline at three months |
| Number of participants with postoperative inflammation and/or infection | Inflammation, infection by clinical exam | Change from baseline at three months |
| Number of upper canines with external root resorption | Periapical radiograph | Change from baseline at three months |
| Bogotá |
| DC |
| 110111 |
| Colombia |